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Saturday, January 14, 2017 11:30:07 AM
The most interesting, and frustrating, part of the study is the wildly high OS of Stage1 AG control. Then the Stage2 had only half the number of control (High HA treated with AG). Stage 2 showed an expected OS <8 but could not overcome the weird Stage 1 control that had twice the N.
The good is that both high and low HA treated with PAG did better than historical AG. But a cohort of selected low HA would like be expected to do better than 8.5 mos anyway. It really is the High HA we care about. (though the future may hold some trials that look to expand the indication to lower HA pancan pts)
The biotech bloggers are very critical of the HR=0.96 in combined 1&2 OS. Rightly so. But it is easy to see where a few outliers made the control unlike historical data. It is nice to see the active PAG arm beat historical numbers. The fly in the ointment is wondering if the higher numbers in both arms might be due to pre-screening out anyone with a clot - about 15% of total. That said, the stage 1 control that did so unnaturally well did not benefit from preselection. It is just weird.
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